Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06011096 |
| Other study ID # |
Erzurum Atatürk Üniversitesi |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2, 2022 |
| Est. completion date |
August 9, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
It is aimed to determine the late cord clamping with early skin-to-skin contact in
primiparous pregnant women who delivered vaginally, according to placental separation time,
separation method, amount of postpartum bleeding and postpartum comfort.
Description:
The research is an experimental type randomized controlled trial. The data of the research
gathered in the delivery room clinic of Erzurum City Hospital affiliated to the Ministry of
Health in Erzurum city center between 02.11.2022 and 10.06.2023. The study was completed with
126 primiparous pregnants, 63 of whom were controls and 63 of whom were experimental,
randomized in the clinic. "Personal Information Form" and "Postpartum Comfort Scale" prepared
by the researcher were used to collect the data of the study.
control group
- Pregnant women who met the criteria for admission to the delivery room were selected,
the institution's routine policies were implemented.
- The mother was informed about the study and written consent was obtained.
- Hospital routine practices continued until birth.
- The stopwatch is started the moment the baby is born.
- After birth, the umbilical cord was clamped immediately without skin-to-skin contact
between the mother and the baby, and the baby was taken to routine care.
- Signs of placental separation were monitored with a stopwatch, and it was noted at what
minute the symptoms were seen.
- Placental delivery time and separation type were noted in the relevant part of the form.
- According to the routines taken from each hospitalized patient in institutional
policies, the volunteer's entry hemoglobin and hematocrit values were noted on the form.
- The Personal Information Form consisting of 22 questions and the Postpartum Comfort
scale were administered to the mother at the end of the follow-up period in the delivery
room (2 hours later).
- From the 6th hour blood values found in the hospital routine, the mother's hemoglobin
and hematocrit values were noted on the form.
Experimental group
- Pregnant women who met the criteria for admission to the delivery room were selected,
the institution's routine policies were implemented.
- The mother was informed about the study and written consent was obtained.
- Hospital routine practices continued until birth.
- The stopwatch is started the moment the baby is born.
- The baby was placed on the mother's chest, it was waited for 60-90 seconds in
skin-to-skin contact, and breastfeeding was tried. At the end of the period, the
umbilical cord was clamped and the baby was placed under a radiant heater and routine
care was continued.
- Signs of placental separation were monitored with a stopwatch, and it was noted at what
minute the symptoms were seen.
- Placental delivery time and separation type were noted in the relevant part of the form.
- According to the routines taken from each hospitalized patient in institutional
policies, the volunteer's entry hemoglobin and hematocrit values were noted on the form.
- During the repair of episiotomy or desuria, if any, in the mother, skin-to-skin contact
was made between the baby and the mother for 1 hour without disrupting the procedures.
- The Personal Information Form consisting of 22 questions and the Postpartum Comfort
scale were administered to the mother at the end of the follow-up period in the delivery
room (2 hours later).
- From the 6th hour blood values found in the hospital routine, the mother's hemoglobin
and hematocrit values were noted on the form.
